# Problem Formulation,

f or Ecological Risk Assessment, f or Fluazinam

June15 , 200 9 Environmental Fate and Effects Division Office of Pesticide Programs U.S. Environmental Protection Agency2 Table of Contents 1. Purpose ................................ ................................ ................................ ................................ .... 3 2. Problem Formulation ................................ ................................ ................................ .............. 3 2.1 Nature of Regulatory Action ................................ ................................ ................................ 3 2.2. Previous Risk Assessments ................................ ................................ ................................ .. 3 3. Stressor Source and Distribution ................................ ................................ ............................ 3 3.1. Mechanism of Action ................................ ................................ ................................ .......... 3 3.2. Overview of Pesticide Usage ................................ ................................ .............................. 5 3.3. Environmental Fate and Transport ................................ ................................ ...................... 8 4. Receptors ................................ ................................ ................................ ............................... 13 4.1. Aquatic and Terrestrial Effects ................................ ................................ ......................... 13 4.2. Incident Database Review ............ Error! Bookmark not defined. Error! Bookmark not defined. 4.3. Ecosy stems Potentially at Risk ................................ ................................ ......................... 18 6. Conceptual Model ................................ ................................ ................................ .............. 19 6.1. Risk Hy

pothesis ................................ ................................ ................................ ............... 19 6.2. Conceptual Diagram ................................ ................................ ................................ ........ 20 7. Analy sis Plan ................................ ................................ ................................ ..................... 21 7.1. Stressors of Concern ................................ ................................ ................................ ......... 22 7.2. Measures of Exposure ................................ ................................ ................................ ....... 22 7.3. Measures of Effect ................................ ................................ ................................ ............ 23 7.4. Integration of Exposure and Effects ................................ ................................ ................. 24 7.5. Deterministic and Probabilistic Assessment Methods ................................ ...................... 24 7.6. Endangered Species Assessments ................................ ................................ ..................... 25 7.7. Drinking Water Assessment ................................ ................................ ............................. 25 7.8. Preliminary

I dentifi cation of Data Gaps ................................ ................................ ........... 25 7.8.1. Fate ................................ ................................ ................................ ............................. 25 7.8.2 Effects ................................ ................................ ................................ ......................... 27 8. Ref erences ................................ ................................ ................................ ................................ 31 Appendix A. SRRD data request justification tables ................................ ................................ .. 323

1. Purpose The purpose of this problem formulation is to provide the foundation for the ec ological risk assessment being conducted for fluazinam . As such, it articulates the purpose and objectives of the risk assessment, evaluates the nature of the problem, and provides a plan for anal yz ing the data and characterizing the risk (EPA, 1998). 2. Problem Formulation 2.1 . Nature of Regulatory Action This report summarizes the Environmental Fate and Effects Division’s (EFED) Problem Formulation for the Registration Review of f luazinam . P revious risk assessment s w ere completed for the uses of the chemical, through 2007, which serve as the basis for this assessment. 2.2. Previous Risk Assessments In 2007, two risk assessments were issued for fluazinam. O ne was an IR - 4 petiti on (dated 5/16/2007 ; DP Barcodes 338293 and 338294 ) for uses on legum e vegetable Crop Subgroup 6A, bushberry Crop Subgroup 13B, brassica leafy vegetable Crop Group 5, ginseng, dry bean, lima bean and succulent bean Crop Subgroup 6B. Chronic L OCs were exceeded for avian (RQs ranged from 3.40 to 0.06) and mammalian (RQs rang ed from 6.80 to 0.12) endangered and non endangered species. In addition, there was acute and chronic risk indicated for aquatic organisms. Since fluazinam is practicall y nontoxic to honey bees, no labeling precautions were required . Risk s to plants were below LOCs. In addition, a risk assessment was issued for the proposed aerial use of fluazinam on potatoes (dated 11/21/07 ; DP Barcode 342007 ) (previously , onl y ground applications were allowed). In the risk assessment, i t was found that chronic LOCs were exceeded for avian (RQs ranged from 1.0 to 1.5) and mammalian (RQs ranged from 0.2 to 3.0) endangered and non - endangered species. C hronic risk was indicated for endangered and non - endangered freshwater fish, estuarine/ marine inv ertebrates and estuarine/ marine benthic organisms . A cute LOCs were exceeded for endangered and non - endangered estuarine/ marine benthic organisms. When comparing ground applications , and aerial applications with and without using a buffer , g enerall y, ground applications produced the lowest risk while aerial applications using buffer zones had RQs that were slightly less than aerial applications without buffers. As in the previous case, no labeling precautions were required to honey bees. Risks to plants were below LOCs. 3. S tressor Source and Distribution 3.1. Mechanism of Action4

Fluazinam, CAS Name: 3 - chloro -N - [3 - chloro - 2,6 - dinitro - 4 - (trifluoromethyl)phenyl] - 5 - (trifluo romethyl) - 2 - py

ridinamine, and IUPAC Name: 3 - chloro -N - (3 - chloro - 5 - trifluoromethyl - 2 - py ridyl ) - α,α,α - trifluoro - 2,6 - dinitro - p - toluidine, has a CAS Number of 79622 - 59 - 61 and a PC Code of 129098. It is a py ridine (dinitroaniline) fungicide. The structure consists of one phenyl ring with two nitro groups, and a p yridine ring. Both rings have a trifluoromethyl group. The rings are attached b y an amine group . The product name is Omega 500F Agricultural Fungicide (EPA Reg. No. 71512 - 1). It contains 40.0% fluazinam. Fluazinam is a protectant and contact fungicide. According to the Fungicide Resistance Action Committee (FRAC) classification scheme of fungicides, fluazinam belongs to the chemical group of 2,6 - dinitroanilines and is classified as FRAC numerical code 29, according to the mode of action, which is inhibition of respiration. Fluazinam is an uncoupler of oxidative phosphorilation in the respiration chain involving protonation/ deprotonation (it inhibits fungal respiration, and the production of energy within the fun gus). Fluazinam belongs to a chemical group classified as a multi - site fungicide (chemicals which act as general toxophores with several sites of action). Table 1 shows the chemical structures of fluazinam and various of its transfo rmation products ( CAPA , D APA , AMPA, DCPA , HYPA, G - 504 and MAPA). Itis noted that all these chemicals (except for G 504, which is a tricyclic compound) are structurally similar (they

have the same backbone structure) . They

are also considered stressors. Table 1. Fluazinam and Various Transformation Products Common Name Chemical Name Structure Fluazinam CAS Name: 3 - chloro -N - [3 - chloro - 2,6 - dinitro - 4 - (trifluoromethyl) phenyl] - 5 - (trifluo - romethyl) - 2 - py

ridinamine; IUPAC Name: 3 - chloro -N - (3 - chloro - 5 - trifluo romethyl - 2 - py

ridyl) - α,α,α trifluoro - 2,6 - dinitro -

p - toluidine

CAPA 3 - chloro - 6 - (3 - chloro - 2,6 - dinitro - 4 -

trifluoromethyl anilino)nicotinic acid; 5 - chloro - 6 - (3 - chloro - α,α,α - trifluoro 2,6 - dinitro - p - toluidino)nicotinic acid N H N

O 2 N O 2 N

Cl CF 3 Cl

HOOC DAPA 3 - chloro -N 4

- (3 - chloro - 5 -

trif luoromethyl - 2 - py

ridyl) - α,α,α trifluorotoluene - 3,5,5 - triamine; 3 - chloro - 2(2,6 - diamino - 3 - chloro - α,α,α trifluoro - p - toluidino) - 5 - (trifluoromethyl) pyridine N H N H 2 N

CF 3 Cl H 2 N Cl

F 3 C

DAPA5

Table 1. Fluazinam and Various Transformation Products Common Name Chemical Name Structure AMPA 2 - (6 - amino - 3 - chloro - α,α,α - trifluoro - 2 -

nitro - p - toluidino) - 3 - chloro - 5 - (trifluoromethyl)pyridine N H N

O 2 N H 2 N

Cl CF 3 Cl

F 3 C DCPA 6 - (4 - carboxy - 3 - chloro - 2,6 -

dinitroanilino) - 5 - chloronicotinic acid N H N O 2 N

COOH Cl O 2 N Cl

HOOC

DCPA MAPA 3 - chloro -N 4

- (3 - chloro - 5 -

trifluoromethyl - 2 - py

ridyl) - 5 - nitro α,α,α - trifluoro - toluene - 3,4 - diamine N H N

H 2 N O 2 N

Cl CF 3 Cl

F 3 C HYPA , Compound XII 5 - [[3 - chloro - 5 - (trifluoromethyl - 2 -

pyridyl]amino] - α,α,α - trifluoro - 4,6 - dinitro - o - cresol N H N O 2 N

CF 3 HO O 2 N Cl

F 3 C G- 504 4,9 - dichloro - 6 - nitro - 8 -

(trifluoromethyl)pyrido - [1,2 - α] - benzimidazole - 2 - carboxylic acid N N O 2 N

CF 3 Cl Cl

HOOC 3.2. Overview of Pesticide Usage A summary

table of all use patterns for fluazinam follows (Table 2).6

Table 2. Summary use information for fluazinam (based on Omega 500F label , EPA Reg. No. 71512 - 1).

USE SINGLE APP. RATE (lb. a.i./A) NUMBER

OF APPS. SEASONAL

APP. RATE (lb. a.i./A) INTERVAL

BETWEEN APP S . (days) APP. METHOD PHI (days) Peanut 0.52 - 1.04 2 2. 09 21 Ground, Sprinkler irrigation Do not

apply w/in 30 d of threshing for harvest Potato 0.18 - 0.26 7 1.82 7 Aerial , Ground, Sprinkler irrigation 14 Crop Subgroup 6A, Edible - Podded Legume Vegetables except peas, such as, but not limited to: Phas eolus spp. Such as: runner bean, snap bean, wax bean; Vigna spp. Such as: asparagus bean, Chinese longbean, moth bean, yardlong bean; jackbean, and sword bean 0.26 - 0.44 2 0.91 7 Ground, Sprinkler irrigation 14

Succulent Bean Crop Subgroup 6B (such as, but not limited to lima bean and broad bean ) 0.26 - 0.44 2 0.91 7 Ground, Sprinkler irrigation 14 Dry Bean Crop Subgroup 6 C , except Peas and Soy beans (such as, but not limited to dried cultivars of bean: Lupinus spp.; Phaseolus spp, such as kidney beans, dry l ima bean, navy bean, pinto bean; Vigna spp., such as adzuki bean; and broad bean, such as lablab bean ) 0.26 - 0.44 2 0.91 7 Ground, Sprinkler irrigation 30

Crop Subgroup 13 - 07 B, Bushberry, such as, but not limited to: Aronia berry, blueberry (highbush and l owbush), Chilean guava, currant (Buffalo, black, red, and Native), elderberry, European barberry, gooseberry, highbush cranberry, honeysuckle, huckleberry, jostaberry, juneberry, lingonberry, salal, and sea buckthorn 0.65 6 3.90 7 Ground 307

Table 2. Summary use information for fluazinam (based on Omega 500F label , EPA Reg. No. 71512 - 1).

USE SINGLE APP. RATE (lb. a.i./A) NUMBER

OF APPS. SEASONAL

APP. RATE (lb. a.i./A) INTERVAL

BETWEEN APP S . (days) APP. METHOD PHI (days) Crop Group 5, Brassica (Cole) Leafy Vegetables, such as, but not limited to: broccoli; broccoli raab (rapini); Chinese cabbage (napa); cauliflower; collards, kale; mizuna; mustard spinach; turnip greens; Chinese broccoli; Brussels sprouts; Chinese cabbage (bok choy); Chinese mustard cabbage; cavalo broccoli; kohlrabi; mustard greens; rape greens [Transplant 6.45 fl oz/100 gal or presumably 0.64 lb a.i./A] Soil incorpo ration 1.36 at a soil depth of 6 - 8 in 1 2.00 N/A Soil drench after transplanting or soil incorporation (transplant the seedlings into the treated band 20;

50 for heading vegetables such as cabbage and broccoli Ginseng 0.52 - 0.78 4 3.1 3 7 Ground 30 F luazinam may

be applied through sprinkler irrigation (through center pivot, motorized lateral move, traveling gun, solid set or portable 1 irrigation sy stems) ; however, it can also be soil incorporated before transplant, for Crop Group 5, b rassica ( c ole) l eafy v egetables , in soils with low infiltration rates . The label requires a buffer zone of 25 ft within perman ent bodies of water (lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, and estuaries) so as to allow growth of a vegetative filter strip. The product should not be applied by aerial equipment within 150 ft of estuarine/ marine areas (aerial applications are currentl y allowed onl y for potatoes) . The product does not require a similar buffer zone for aerial applications on freshwater bodies of water (for freshwater bodies of water, a 25 - ft buffer applies) . The SLUA summary

for fluazin am is as follows (Table 3) : Table 3. Screening - Level Estimates of Agricultural Uses of Fluazinam (SLUA , 10/03/08) Crop lb a.i. Percent (%) Crop Treated Average Maximum Peanuts 10,000 <2.5 5 Potatoes 60,000 10 20 The sources of the SLUA include the USDA - NASS (2001 - 2006), Private Pesticide Market Research (2001 - 2007), the National Use Database (NPUD 2002) of the CropLife America Foundation and California Department of Pesticide Regulation (CDPR) data. The information is amalgamated and put in a publ ic releasable format. The U.S. Geological Survey (USGS) pesticide use map (Fig. 1) shows regional scale patterns in use intensity

within the United States. The USGS pesticide maps are based on State level estimates of pesticide use rates for individual c rops, which have been compiled by the National Center for Food and Agri cultural Policy (NCFAP) for 1999 through 2004 , and on the 2002

1 Wheel move, side roll, end tow, or hand move portable irrigation systems.8

Census of Agriculture for county crop acreage crop. Itis n ote d that based on the uses at the time there were already pot ential estuarine/ marine areas of concern in the East coast. The only uses for fluazinam available through the time covered b y the map were peanuts and potatoes. Based on the map information , potatoes used roughly two thirds of the fluazinam applied (>63 ,000 lb) , while peanuts covered roughly one third (>31,000 lb) .

Fig. 1 . Use of F luazinam in 2002 . Note of Caution: The pesticide use maps available from th e web ( http://water.usgs.gov/nawqa/pnsp/usage/maps/compound_listing.php?year=02 ) show the average annual pesticide use intensity expressed as average weight (in pounds) of a pesticide applied to each square mile of agricultural land in a county. The area of each map is based on state - level estimates of pesticide use rates for individual crops that were compiled by the CropLife Foundation, Crop Protection Research Institute during based on information collected during 1999 through 2004 and on 2002 Census of Agriculture county crop acreage. The maps do not represent a specific year, but rather show typical use patterns over the five year perio d 1999 through 2004. Us e intensity rates are expressed as the pounds applied per square mile of mapped agricultural land in a county. The area of mapp ed agricultural land for each county was obtained from an enhanced version of the 1992 USGS National Land Cover Data (NLCD). The key limitations of the data used to produce these maps include the following: (1) state use coefficients represent an average for the entire state and consequent ly do not reflect the local variability of pesticide management practices found within states a nd counties, (2) pesticide use estimates are not for a specific year, but represent typical use patterns for the five year period, (3) state pesticide use coefficients may not have been available for all state s where a pesticide may have been applied to ag ricultural land, and therefore, are not displayed on the maps, (4) the county crop acreage is based on the 2002 Census of Agr iculture and may not represent all crop acreage because of Census nondisclosure rules, and (5) agricultural land area used to calcu late the pesticide use intensity and display the data was derived from 30 - meter satellite remote sensing data that may over estimate or underestimate the actual agricultural land area. The maps are not intended for making local - scale estimates of pesticide use, such as estimates at the county level. Please refer to Method for Estimating Pesticide Use for a detailed discussion of how the pesticide use data were developed. 3.3. Environmental Fa te and Transport A summary

of phy sic o chemical and environmental fate/transport properties of fluazinam is included in Table 4 .9

Table 4 . Summary of Various Physico c hemical and Environmen tal Fate Properties of Fluazinam

Parameter Value Reference/Comments * Selected Physicochem ical Parameters Water Solubility (25 o C) 0.025 mg/L @ pH 5.5, 0.071 @ pH 7.0 MRID 42208403 Vapor pressure 8.25x10 - 6 mm Hg MRID 42248403 Molecular Formula C 1 3 H 4 C l 2 F 6N 4 O 4 Molecular Weight 465.1 g/mol CAS No. 79622 - 59 - 6 CAS name 3 - chloro -N - [3 - chloro - 2,6 - dinitro - 4 - (trifluoromethyl)phenyl] - 5 - (trifluoromethyl) - 2 - pyridinamine IUPAC name 3 - chloro -N - (3 - chloro - 5 - trifluoromethyl - 2 - py ridyl) - α,α,α - trifluoro - 2,6 - dinitro - p toluidine Henry’s Law Constant 6.73 x 10 - 7 atm- m3 /mol at pH 7 PMRA Reg. Note REG2003 - 12 Octanol/Water Partition, Log KOW 3620, 3.56 @20°C MRID 42248403 Persistence: Fluazinam Fluaz.+Degradates Hydrolysis t 1/2 pH 5

pH 7 pH 9 stable

42 days 6 days stable

stable stable MRID 42208412 (a) Photolysis t 1/2 in water 2.5 days, dark control ≈stable one degradate (G 504) MRID 44807312, 43521009 , 45584204

( a) on soil 35.0 days, value

corrected for dark control degradates at

≤10% of the applied MRID 44807313 , 45584204 ( a) Soil metabolism Aerobic t 1/2 114 - 132 days for samples treated at 1 kg/ha (5.56 ppm) degradates at

≤10% of the app. ; HYPA was 11.4% at 30 days (for soil treated at 5 kg/ha) MRID 42208413 , 42208414 (a)

Soil metabolism Anaerobic t 1/2 SL flooded at time 0, 4 days; SL flooded at 30 days, 32 days HYPA was 11.0%

at 60 days for the spl. flooded at 30 days . MAPA was up to 29.8% for the sample flooded at time 0. MRID 42208413, 42208414 (s)

Aquatic metabolism Aerobic DT 50 4.0 - 7.4 hours 51 - 71 days MRID 44807314 (a) Aquatic metabolism Anaerobic t 1/2 ≈ 1⁄3 day (or approximately 8 hours) stable MRID 4352101 0 (a)10

Table 4 . Summary of Various Physico c hemical and Environmen tal Fate Properties of Fluazinam

Parameter Value Reference/Comments * Mobility/Adsorption -

Desorption Batch Equilibrium - Unaged Batch Equilibrium HYPA Batch Equilibrium CAPA Aged Soil Column Leaching 4 soils KF =11 - 44 KFOC =1700 - 2300 KF, des =34 - 507 KFOC, des =7000 - 19900 6 soils Kd=6.6 - 51 KOC =640 - 32 00 KF =4.3 - 26 KFOC =450 - 1700 Increasing adsorption w. increasing pH 4 soils KF =4.9 - 67 KFOC =1289 - 3784 Studies on HYPA and CAPA were conducted w. sterile soils. 0.66% in leachate MRID 42248628, 42974913 (a) MRID 43528201 (a) MRID 44807 315 (s) MRID 42208415 (a) Field Dissipation Terrestrial Dissipation

t 1/2 in soil surface layer Range from 9 to 49 days: Ephrata, WA: DT50~9 days loamy sand, pinto beans; Kempton, ND: half - life=49 days, sandy loam, beans; Porterville, CA: half - life=20 day s, loamy sand, beans; Montezuma, GA The degradation was biphasic. MRID 44807318, 44807320, 44807316 (s)

Bioaccumulation Accumulation in Fish, max. BCF 273 - 348 X for fillet portion 960 - 1220 X for whole fish 1410 - 1850 X for non - edible

~ 67% of the resi dues eliminated from the fillet during the 21 - day depuration phase MRID 43521012 (a)

(a) = acceptable or core study that fulfills guideline requirement; (s) = supplemental study; (u) = unacceptable study Where two values are stated, they may correspond to two radiolabel positions. F luazinam appears to degrade at moderate to low rates in aerobic soils (132 day s) , but it is more rapidly transformed into other compounds of similar backbone structure in high pH solutions (6 day s at pH 9) or in aerobic ( ≤7.4 hr) or anaerobic aquatic (~8 hr) media. The transformation products of fluazinam appear to be relativel y persistent under most conditions. Fluazinam may be photoly sed relativel y rapidly in water (2.5 days) to form a tricyclic compound (G - 504) . The total fluazinam residues (fluazinam and its transformation products) are persistent in most environments ( stable to hydroly sis at all pHs , aerobic aquatic metabolism 51 - 71 day s, relatively stable in anaerobic aquatic environment) and are likely to reach a quatic media as a totality through runoff. Since fluazinam does not alter substantially its backbone structure in the environment, but instead, goes through slight transformation s of functional groups, EFED considered parent and transformation products to gether when making assessments. While the parent and two transformation products, HYPA and CAPA, have relativel y low mobility, indicating low potential for ground water contamination, there is uncertainty about the other transformation products and further information on them was required in a new Terrestrial Field Dissipation s tudies . Two such studies (MRID#’s 45584207 and 455842 08 ) are currently in review. Based on the properties of the chemical, applications of fluazinam are likel y to reach the11

target (the crop), but drift is also possible. The total residues of fluazinam may reach adjacent bodies of water via runoff events and may be persistent. The chemical has a low vapor pressure ( 8.25x10 - 6 mm Hg) , and a relativel y low Henry ’s Law constant ( 6.73 x 10 - 7 atm - m 3 /mol) . Due to the fact that it appears to show short half lives in aquatic media, and it binds to soils, EFED believes that the chemical would not volatilize substantially . Hydrolysis The hydroly sis of fluazinam is pH dependent. It was relativel y stable at pH 5, and hydrol yz ed with half - lives of 42 and 6 day s at pH’s of 7 and 9, respectivel y. The major degradate was CAPA. Photolysis Fluazinam photoly ses in aqueous solutions , mainly to G - 504, a tricyclic compound, and possibly one or more other unidentified products. The half - life obtained in the study was 2.5 day s. The soil photolysis, on the other hand, the half - life was 22 day s (compared to 69 day s for the dark control). The dark co ntrol corrected half - life is 35 day s. Metabolism The metabolism of fluazinam appears to be moderate in a sandy loam soil treated at 1 kg/ha (5.56 ppm) (DT 50 ≤ 30 day s). The calculated half - life (linear regression, assuming fir st order kinetics) was about 114 - 132 day s, which is in agreement with the fact that after 361 days, 6.8 and 9.5% of the applied fluazinam remained intact for the 14 C - Py ridyland 14 C - Phenyl labels, respectivel y ; no major metabolites were observed . The sandy loam treated at 5 kg/ha yi elded a half - life of 227 day s ; in this case, Compound XII (HYPA) was observed at up to 11.4% at 30 day s posttreatment . A loamy sand treated at 1 kg/ha yielded a half - life of 165 day s with no major metabolites . No major degradation products were observed in th e samples treated at 1 kg/ha , but a major fraction (~41%) was bound material at the end of the study (day 361). Sediment/Water Systems The aerobic aquatic and the anaerobic aquatic m etabolism studies resulted in very short half

lives ( ≤8 hours in both studies). In addition, in such studies, various metabolites were formed. All the major transformation products observed have structures that resemble the structure of the parent. The sum of the amount of the parent concentration plus the concentrations of the transformation products (total fluazinam residues) decreases very slowl y under both aerobic (half - lives 51 - 71 day s) and anaerobic (relativel y s table) aquatic conditions . The major transformation products obs erved in these studies include DAPA, SDS - 67200, AMPA, DCPA, and CAPA. Mobility In batch equilibrium studies, fluazinam is slightly mobile in four soils tested. K F OC values ranged from 1705 - 2316. Similarly, an available soil column leaching study of aged fluazinam indicated low mobility

of the residues of fluazinam. L ess than 1% of the applied radiocarbon was found in the leachates and >>80% remained at the top of the soil columns. There is mobility information for two of the transformation products of fluazinam: HYPA and CAPA. Of them, HYPA appeared to be moderately to slightly mobile (KF OC = 450 - 1700 , 6 soils), and CAPA12

appeared to be slightly

mobile, but generall y less mobile than the parent (K F OC =1289 - 3784, 4 soils). The latt er two batch/equilibrium studies were conducted on sterile soils. Field Dissipation Four terrestrial field dissipation studies were submitted by the registrant. Such studies were found to provide only

limited supplemental information. In particular, the data about the degradates is very

questionable due to poor recoveries in a storage stability study . In general, it appeared that parent fluazinam degraded moderately rapidly in studies conducted in Ephrata, Washington, Kempton, North Dakota, Porterville, California, and Monctezuma, Georgia. The dissipation half

- lives ranged from 9 to 49 day s. These half - lives are in agreement with the aerobic soil metabolism half - li ves . At this time, the EFED has two newl y submitted terrestrial field dissipation studies, which are in review. Bioaccumulation Fluazinam demonstrated some potential to bioaccumulate in fish. The maximum BCF’s were 348X for fillet, 1220 for whole fish, and 1850 for viscera, all of which were obtained with the phenyl label material. Fish residues identified included the parent compound, AMPA, MAPA and DAPA. Depuration was moderately slow . More than 67% of the residues were eliminated from the fillet during the 21 - day depur ation phase. The fate and transport characterization also includes the various degradation and transformation products formed b y each process in the studies reviewed . Table 5 provides a summary of these transformation products. Table 5 . Summary of d egr adate formation from degradation of fluazinam.

STUDY TYPE DEGRADATE and MAXIMUM CONCENTRATION SOURCE CAPA, G - 504, HYPA AMPA, MAPA, DAPA, DCPA (% applied) Hydrolysis CAPA 34% at 28 days pH 7; 84 - 85% at 20 days at pH 9 – – MRID: 4 2208412 . Aqueous Pho tolysis G - 504 was 14.0 - 17.1% by 7 - 10 days _ – MRID: 4 44807312, 43521009 , 45584204 . Soil Photolysis HYPA, detected > dark control AMPA detected > dark control – MRID: 4 4807313 , 45584204 . Aerobic Soil Metabolism HYPA, MAPA and DAPA detected (in the SL studies conducted at 1 kg/ha) MRID: 4 2208413, 42208414 . Anaerobic Soil Metabolism HYPA was 11.0% at 60 days for the SL flooded at 30 days MAPA was 29.8% at 14

days for the SL flooded at zero time – MRID: 4 2208413, 42208414 . Aerobic Aquatic Metabolism CAPA 12.6 % at 72 hr DAPA: 19.0% by 240 hr DCPA: 11.3% at 24 hr MRID: 4 4807314 . Anaerobic Aquatic Metabolism AMPA 24.2% at 0.2 day DAPA: 32.7% at day 30 SDS - 67200 39.6% by day 14 MRID: 4 3521010 . Terrestrial Field Dissipation MAPA, CAPA, and HYPA were mo nitored; however, there were problems with the storage stability data for the degradates. MRID: 44807318, 44807320, 44807316, 44807319, 44807317 .13

4 . Recepto rs 4. 1. Aquatic and Terrestrial Effects The receptor is the biological entity that is exposed to the stressor (EPA, 1998). Due to the outdoor uses of fluazinam, the ty pes of receptors that may be exposed include both aquatic and terrestrial receptors, such as birds, reptiles, mammals and freshwater and estuarine/ marine fish, non - target invertebrates and terrestrial and aquatic plants. This list may not be comprehensive. Spray drift and runoff exposures are expected for both ground and aerial (potato only) applications of fluazinam. Consistent with the process described in the Overview Document (EPA, 2004), this risk assessment uses a surrogate species approach in its evaluation of fluazinam . T oxicological data generated from surrogate test species, which are intended to be representative of broad taxonomic group s, are used to extrapolate to potential effects on a variety of species (receptors) included under these taxonomic groupings. Table 6 provides a summary of the taxonomic groups and the surrogate species tested to help understand potential ecological ef fects of pesticides to these non - target taxonomic groups. In addition, the table provides a preliminary overview of the potential acute toxicity of f luazinam by providing the acute toxicity classifications . Terrestrial Species The available toxicity

data suggests that fluazinam ranges from slightly toxic to practically nontoxic for birds . An LD 50 =1782 mg/kg per body weight for quail (MRID 422486 - 23) is the most sensitive endpoint and will be used in the risk assessment. A quail L C 5 0 >10500 mg/kg (MRID 422486 - 24) as well as a mallard LD 50 > 4191 mg/kg (M RID 422486 - 22) and an LC 50 >10, 6 00 mg/l (MRID 422486 - 25) indicate that fluazinam is practically nontoxic to birds. A twenty- two week quail reproductive study resulted in a NOEL=200 mg/kg for 14 - day survivor weight . A twenty- one week avian reproduction toxicity study (MRID 448319 - 07) show s that fluazinam exposure can result in growth red uction in young (14 - day

old survivors weight) with a NOAE L = 200 m g/kg and L OAE L = 500 mg/kg . Mammal ian toxicity

data (MRID 422486 - 03 ) sug gest that this compound is practicall y nontoxic to small mammals on an acute basis (rat LD 50 = 4,300 mg/kg). Reproductive effects that were based on a decreased number of implantation sites and decreased litter size were noted at an LOAEC = 500 ppm (NOAEC = 100 mg/kg). Terrestrial invertebrates are represented b y the honey bee. Acute toxicity on honey bees show that fluazinam is practically nontoxic to bees based on an LD 50 > 200 μ g a.i. /bee (MRID 422084 - 11) . A toxicity test for the formulated product was also provided. A 48 - h LD 50 >4.0 μg/bee indicates this fluazinam product (49.7%) is practically non - toxic to bees.14

Aquatic Species The effect of fluazinam to freshwater fish is estimated for both cold and warm water fish. Fluazinam is consi dered to be very highly toxic to the freshwater rainbow trout ( Oncorhynchus mykiss) on an acute basis , with an LC 50 = 36 μg/l (33 - 56 μg/l) (MRID 429749 - 04) . This rainbow trout estimate is the most sensitive value and will be used in the risk assessment. Another rainbow trout study

(MRID 422084 - 09) resulted in an L C 50 =110 μg/l (100 - 130 μg/l) . Another fish study for the bluegill resulted in an LC 50 = 52.7 μg/l (47.1 - 59 μg/l) , indicating fluazinam is very highl y toxic to fish (MRID 42 9749 - 0 5 ). An invalid non - guideline toxicity study for the carp ( Cyprinus carpio ) was also submitted (MRID 422084 - 08). In addition to the acute fish studies, two chronic studies, an early life and a life - cycle study , were submitted. A c hronic freshwater life cycle fish study resulted in a 278 day NOAEC =0.69 μg/l for a fathead minnow (MRID 448073 - 29) based on hatching success . A chronic study resulted in a NO AEC=5.3 μg/l and a LOEC - 10 μg/l for a 30 day earl y life test (MRID 448073 - 27) with larval survival a s the endpoint effected. Daphnia are used as a surrogate for freshwater invertebrates for both acute and chronic effects . Acute toxicity

values for aquatic invertebrates suggest that fluazinam is highly toxic to freshwater invertebrates ( Daphnia EC 50 = 18 0 μg/l (MRID 422084 - 10) to 222 μg/l (MRID 429749 - 06 ). Chronic toxicity to invertebrates is only

represented through the Daphnia magna life cycle (MRID 448073 - 28) where th e NOAEC was calculated at 68 μg/l and the LOAEC at 0.140 μg/l . The endpoints affect ed for this study were reproductive and weight effects. Estuarine/marine fish are represented b y the sheepshead minnow ( Cyprinodon variegatues ) with a toxicity study indicating fluazinam is highl y toxic to estuarine/marine fish . An acute toxicity study (M RID 448073 - 2 5 ) resulted in L C 50 = 120 μg/l ( 80 - 240 μg/l). The chronic fish early life stage study was classified as supplemental and resulted in a NOEL> 26 μg/l (MRID458221 - 02). This study

does not satisfy

the guideline requirement for a chronic estuarine/m arine fish study. Estuarine/marine aquatic invertebrates are represented by the o ys ter and my sid with toxicity studies indicating fluazinam is very highl y toxic to both. An acute toxicity study (MRID 448073 - 24) resulted in an o ys ter ( Crassostrea virginic a ) EC 50 = 4 . 7 μg/l (3.6 - 6.0 μg/l). The acute study (MRID 448073 - 26) for the my sid shrimp ( Americamysis bahia ) resulted in an EC 50 = 39 μg/l (34 - 45 μg/l ) . The results from the oy ster study will be used in this assessment because it resulted in the most se nsitive acute endpoint. A chronic m ysid reproductive study (MRID 458221 - 01 was classified as supplemental based on missing raw data . The missing information has been requested from the conditional registration data call - in . Plants An acceptable seedli ng emergence Tier I study (MRID 461728 - 01) using the dicots cabbage, carrot, cucumber, lettuce radish, soy bean and tomato and the monocots corn, oat , onion and ryegrass was rece i ved . The toxicity test resulted in an EC25>0.78lbs a.i./A based on no observed effects at the highest tested concentration. .15

Terrestrial The effect of fluazinam on terrestrial plants is represented through the seedling emergence and vegetative vigor studies. An acceptable seedling emergence study (MRID 461728 - 01) resulted in no effect at the highest tested concentration of 0.78 lb/A. A Tier I terrestrial seedlin g emergence study (MRID 448073 - 32 and 448073 - 33) resulted in a 14 day EC 25 <1.5 lb/A for tomato. No acceptable vegetative vigor studies have been submitted. Aquatic Plant

s The effect of fluazinam on aquatic plants is represented by vascular and nonvascular species. No acceptable vascular aquatic plant studies have been submitted , but a Lemna study was requested in the conditional registration . One acceptable nonvascular p lant study w as submitted. An acceptable blue - green algae ( Anabaena flos - aquae ) study (MRID 458221 - 06) resulted in an EC 50 =9200 μg/l. A supplemental study with the green algae Pseudokirchneriella subcapitata ) , a surrogate for nonvascular aquatic plants , wa s submitted and resulted in a 96 hour EC 50 =180 μg/l (160 - 200 μg/l) (MRID 448073 - 34). This study does not satisfy the nonvascular plant requirement. Several invalid nonvascular studies were submitted (MRIDs 445221 - 04, 458221 - 05 and 458221 - 07). Table 6 . T est Species Evaluated for Assessing Potential Ecological Effects of F luazinam and the Associated Acute Toxicity Classification Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification

Birds 1 Bobwhite ( Colinus virginianus ) Quail 14d LD 50 =1782 mg/kg ( MRID 42248623) Slightly toxic Quail 8d LC 50 > 10500 mg/kg body weight (MRID 422486 - 24) Practically non - toxic Avian Reproduction Bobwhite Quail 2 2 we ek NOEL=200 mg/kg (MRID 448073 - 23) Mallard ( Anas platyrhync hos ) Mallard 14d LD 50 >4191mg/kg (MRID 422486 - 22) Practically nontoxic Mallard LC 50 > 10600 mg/kg Mallard NOEC = 651 mg/kg (MRID 422486 - 25) Practically Non - toxic16

Table 6 . T est Species Evaluated for Assessing Potential Ecological Effects of F luazinam and the Associated Acute Toxicity Classification Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification Avian Reproduction Mallard Duck 21 week LOEL=500 mg/L (MRID 44831907) Mammals Laboratory rat (Rattus norvegicus ) LD 50 = 4300 mg/kg (MRID 422486 - 03 ) Practica lly Non Toxic Insects Honey bee ( Apis mellifera L. ) 48 h LD 50 >200 μg/bee for (MRID 422084 - 11) P ractically nontoxic 48 h LD 50 >4.0 μg/bee for 49.7%a.i. (MRID 422084 - 11)

Freshwater Fish2 BlueGill ( Lepomis macrochirus ) Bluegill LC50=52.7 μg/L (47.1 - 59 μg/L) (MRID 429749 - 05) Very highly toxic

Rainbow trout ( Oncorhynchus mykiss ) Rainbow trout LC5 0=110 μg/L (100 - 130 μg/L) (MRID 422084 - 09) Highly toxic Rainbow trout LC50=36 μg/L (33 - 56μg/L) (MRID 429749 - 04) Very highly toxic Carp ( Cyprinus carpio ) Carp 96h LC50=145 μg/L (120 - 222 μg/L) (MRID 422084 - 08) Highly toxic

Fathead minnow (Pimephales promelas ) Early life 30d NOEC=5.3 μg/L LOEC=10 μg/l (MRID 448073 - 27) Life cycle 278d NOEC = 0.69 μg/L LOEC=1.4 μg/l (MRID448073 - 29) Acceptable Aquatic Invertebrates Daphnia magna Ac ute Daphnia EC50=180 μg/L (140 - 222 μg/L) (MRID 422084 - 10) Highly to xic17

Table 6 . T est Species Evaluated for Assessing Potential Ecological Effects of F luazinam and the Associated Acute Toxicity Classification Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification Ac ute Daphnia EC50=222 μg/l (MRID 429749 - 06) Highly toxic Lifecycle Daphnia NOEC=68 μg/L 21d LOEC=140 μg/L (MRID448073 - 28) Estuarine/marine fish Sheepshead minnow (Cyprinodon variegatues) 96h LC50=120 μg/l ( 8 0 - 240 μg/l)(MRID 448073 - 25 Highly toxic Chronic: NOEC >26 μg/l all endpoints (MRID 458221 - 02) Supplemental (Not Repairable)

Estuarine/marine invertebrates My sid shrimp (Americamysis bahia) Ac ute Mysid 96h LC50=39μg/l (34 - 45 μg/l)(MRID 448073 - 26 Very highly toxic Chronic NOEC= 2.0 μg/l reproductive success (MRID 458221 - 01) Supplemental (May

be Upgraded) Eastern oyster ( Crassostrea virginica) Ac ute oyster 96h LC50=4.7 μg/l (3.6 - 6.0 μg/l) (MRID 448073 - 24) Very highly toxic

Terrestrial plants 3 Monocots

– corn (Zea mays ) Dicots

– Tomato (

Lycopersicon esculentum ) VV E: Tomato 14D EC25<1.5lb/A (MRID 448073 - 32 and MRID 448073 - 33) Tier I SE: EC25> 0.78 lb/A (MRID 461728 - 01) Acceptable Monocots

– corn (Zea mays ) Dicots

– Tomato (

Lycopersicon esculentum ) Tier I Vegetative Vigor (MRID 461728 - 02) Invalid

Aquatic plants and algae Duckweed ( Lemna gibba ) Lemna

–Required (MRID 458221 - 03) invalid Green algae (Pseudokirchneriella subcapitata ) Algae 96h EC50=180μg/l (160 - 200 μg/l) (MRID 448073 - 34) Supplemental (MRID 445221 - 04) Invalid Blue green Algae (

Anabaena flos aquae) 96 h EC50=9200μg/l (MRID 458221 - 06 Acceptable18

Table 6 . T est Species Evaluated for Assessing Potential Ecological Effects of F luazinam and the Associated Acute Toxicity Classification Taxonomic Group Example(s) of Surrogate Species Acute Toxicity Classification Freshwater D iatom (

Navicula pelliculosa) (MRID 458 - 221 - 05) Invalid Marine Diatom ( Skeletonema costatum ) (MRID 458221 - 07) Invalid 1 Birds represent surrogates for terrestrial - phase amphibians and reptiles. - 2 Freshwater fish may be surrogates for aquatic - phase amphibians. 3 Four species of two families of monocots, of which one is corn; six species of at least four dicot families, of which one is soybeans. 4.2. Incident Database Review In cident Reports : There are no aquatic or terrestrial ecolo gical incident reports for fluazinam in the Agency ’s Ecological Incident Information Sy stem (EIIS). No incidents of contamination of surface, ground and drinking water have been reported to the Agency . A lack of reported incidents does not necessarily me an that such incidents have not occurred. In addition, incident reports for non - target plants and animals ty pically provide information on mortality events onl y. Reports for other adverse effects, such as reduced growth or impaired reproduction, are rare ly received. 4.3 . Ecosystems Potentially at Risk F luazinam may

be applied on a variety of food crops , including beans leafy vegetables, bushberries, ginseng, peanuts and potatoes. Thus, the ecos ys tems at risk may be extensive in scope, and as a result it may not be possible to identify specific ecos ys tems during the development of a baseline risk assessment. In general terms, terrestrial ecosy stems potentially at risk due to the use of f

luazinam , could include the treated field and areas immediately a djacent to the treated field that may receive drift or runoff. Areas adjacent to the treated field could include cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats and other uncultivated areas. Due to the persistence of the total residues of f luazinam (that is, total residues of parent and its transformation products) , they are expected to drift and / or runoff due to application to food crops, resulting in possible exposure to aquatic ecos ys tems. Aquatic ecosy stems potentially at risk due to the use of f luazinam include water bodies adjacent to, or down stream from, the treated field and might include impounded bodies such as ponds, lakes and reservoirs, or flowing waterway s such as streams or riv ers. For uses in coastal areas, aquatic habitat also includes marine ecos ys tems, including estuaries. 5 . Assessment Endpoints Assessment endpoints are defined as “explicit expressions of the actual environmental value that is to be protected.” Defining an assessment endpoint involves two steps: 1) identifying the valued attributes of the environment that are considered to be at risk; and 2) operationally19

defining the assessment endpoint in terms of an ec ological entity ( i.e. , a community

of fish and aquatic invertebrates) and its attributes ( i.e. , survival and reproduction). Therefore, selection of the assessment endpoints is based on valued entities ( i.e. , ecological receptors), the ecos ys tems potential ly

at risk, the migration pathway s of pesticides, and the routes by which ecological receptors are exposed to pesticide - related contamination. The selection of clearl y defined assessment endpoints is important because they provide direction and boundaries in the risk assessment for addressing risk management issues of concern. Changes to assessment endpoints are typicall y estimated from the available toxicity studies, which are used as the measures of effects to characterize potential ecological risks ass ociated with exposure to pesticides, such as f luazinam . To estimate exposure concentrations, the ecological risk assessment considers a single application at the maximum application rate to fields that have vulnerable soils. The most sensitive toxicity

endpoints are used from surrogate test species to estimate treatment - related direct effects on acute mortality and chronic reproductive, growth and survival assessment endpoints. Toxicity

tests are intended to determine effects of pesticide exposure on birds, mammals, fish, terrestrial and aquatic invertebrates, and plants. These tests include short - term acute, sub - acute, and reproduction studies and are ty picall y arranged in a hierarchical or tiered sy stem that progresses from basic laboratory tests to ap plied field studies. The toxicity studies are used to evaluate the potential of a pesticide to cause adverse effects, to determine whether further testing is required, and to determine the need for precautionary label statements to minimize the potential adverse effects to non - target animals and plants. 6 . Conceptual Model For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathw ay is the means by

which a pesticide moves in the environment from a source to an ecological receptor. For an ecological pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecologi cal receptors, and a feasible route of exposure. A conceptual model provides a written description and visual representation of the predicted relationships between f

luazinam , potential routes of exposure, and the predicted effects for the assessment endpo int. A conceptual model consists of two major components: risk hy pothesis and a conceptual diagram (EPA, 1998). 6. 1. Risk Hypothesis Risk hy potheses are specific assumptions about potential adverse effects (i.e., changes in assessment endpoints) and may be based on theory

and logic, empirical data, mathematical models, or probability

models (EPA 1998). For this assessment, the risk is stressor - initiated, where the stressor is the release of fluazinam into the environment. The following risk hy pothesis is presumed for this screening - level assessment:20

The use of

f luazinam will likely involve situations where terrestrial and aquatic animals and plants will be exposed to the chemical and/or its transformation products. Based on information on environmental fate, mode of action, direct toxicity and potential indirect effects, EFED assumes potential , for fluazinam and its transformation products, to cause reduced survival, growth, and reproduction to terrestrial and/or aqu atic animals and plants as a result of the proposed use of the pesticide. The conceptual model is a generic graphic depiction of the risk hy pothesis. It includes the potential pesticide or stressor , fluazinam ( and its transformation products ), the sourc e of the pesticide and/or transport pathway s, exposure media, exposure point, biological receptor ty pes, and attribute changes. 6. 2. Conceptual Diagram The conceptual site model is a generic graphic depiction of the risk hy p othesis, and assumes that the fungicide fluazinam (and its transformation products) , having outdoor uses, is capable of affecting aquatic and terrestrial animals provided that environmental concentrations are sufficiently

elevated as a result of proposed l abel uses. Based on an examination of the phy sic o chemical properties of fluazinam, the fate and disposition in the environment, and mode of application, a conceptual model was developed that represents the possible relationships between the stressors, eco logical receptors, and the assessment endpoints. Through a preliminary

iterative process of examining available data, the conceptual model ( i.e. , the representation of the risk hy pothesis) may

be refined to reflect the likely exposure pathway s and the org anisms that are most relevant and applicable to this assessment (see F igure 2, below). It includes the potential pesticide or stressor (fluazinam and its transformation products), the sources and/ or transport pathway s, exposure media, exposure points, bio logical receptor types and attribute changes. In order for a chemical to pose an ecological risk, it must reach ecological receptors in biologicall y significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor. For an ecological exposure pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, and a feasible route of exposure. In a ddition, the potential mechanisms of degradation/ transformation ( i.e. , which degradation/ transformation products may form in the environment, in which media, and how much) must be understood, especially

for a chemical whose metabolites/ transformation pr oducts are of greater toxicological concern than the parent compound. The assessment of ecological exposure pathway s, therefore, includes an examination of the source and potential migration pathway s for constituents, and the determination of potential exposure routes. Under the possible use s of fluazinam, the sources and mechanisms of release of the compound are from ground or aerial (only for potatoes) spray applications. Surface runoff from the areas of application is assumed to depend on factors such as topograph y, irrigation, and rainfall events. Direct deposition may

result in contamination of food items that may be consumed by

terrestrial organisms. Spray

drift results in contaminated adjacent areas, such as bodies of water.21

For aquatic receptor s, the major point of exposure is through direct contact with the water column, sediment, and pore water (gill/ integument) contaminated with spray drift (from spray application) and/ or runoff from treated areas. Indirect effects to aquatic organisms (especiall y fish) can also occur through impact to various food chains. The representative aquatic receptors are certain freshwater and estuarine/ marine fish, invertebrates, and, in certain cases, aquatic plants. The major point of exposure for terrestrial animals is consumption of food contaminated with residues such as grass, foliage, and small insects. For plants, the point of exposure is root uptake. The representative terrestrial receptors are mammals, birds, and, in certain cases, terrestrial plants . The attribute changes used to assess risk terrestrial receptors depend on the ty pe of test ( e.g. , reduced survival, growth, or reproduction for animals and seedling emergence and vegetative vigor for plants ). Itshould be noted, that these species do n ot cover all the possible species in the animal and plant kingdoms; certain taxa are considered as surrogates for other taxa. For example, fish are considered surrogates for aquatic phase amphibians.

7 . Analysis Plan In order to address the risk hy pothesis, the potential for adverse effects on the environment is estimated. Usage, environmental fate and transport, and ecological effects of fluazinam are characterized and integrated to assess the risks. This is accomplished using a risk quotient (ratio22

of exposure concentration to effects concentration) approach. Although risk is often defined as the likelihood and magnitude of adverse ecological effects, the risk quotient - based approach does not provide a quantitative estimate of likelihood and/or magnitude of an adverse effect. However, as outlined in the Overview Document (USEPA 2004), the likelihood of effects to individual organisms from particular uses of a chemical is estimated using the probit dose response slope and either the l evel of concern (discussed below) or the actual calculated risk quotient value. This analy sis plan will be revisited and may be revised depending upon the data available in the open literature and the information submitted by the public in response to the opening of the Registration Review docket. 7.1. Stressors of Concern The focus of this assessment is on the fluazinam, p arent material . However, the Agency will review open literature to identify degradate(s) of potential toxicological concern. Vario us degradates of fluazinam, such as HYPA, are structurally related to the parent compound, and persist more than fluazinam. T oxicity data for environmental mixtures of fluazinam with other pesticides (those mixtures occurring in the environment following application), if available, may be presented as part of the ecological risk assessment. It is expected that the toxic effect of fluazinam , in combination with other pesticides used in the environment, is likely to be a function of many factors including b ut not necessaril y limited to: (1) the exposed species, (2) the co - contaminants in the mixture, (3) the ratio of fluazinam and co - contaminant concentrations, (4) differences in the pattern and duration of exposure among contaminants, and (5) the differenti al effects of other phy sical/ chemical characteristics of the receiving waters ( e.g. organic matter present in sediment and suspended water). Quantitativel y predicting the combined effects of all these variables on mixture toxicity to any given taxa with confidence is beyond the capabilities of the available data and methodologies. However, a qualitative discussion of implications of the available pesticide mixture effects data on the confidence of risk assessment conclusions will be addressed as part of the uncertainty anal ys is. 7.2. Measures of Exposure In order to estimate risks of fluazinam exposures in aquatic and terrestrial environments, all exposure modeling and resulting risk conclusions will be made based on maximum application rates for the current use patterns. Measures of exposure are based on aquatic and terrestrial models that predict estimated environmental concentrations of fluazinam (plus its transformation products) using maximum labeled application rates and methods, as well as any m itigation measures spec ificall y indicated on the label . The models used to predict aquatic EECs are the Pesticide Root Zone Model coupled with the Exposure Anal ys is Model System (PRZM/EXAMS). The model used to predict terrestrial exposure is T - REX. The model used to derive EECs relevant to terrestrial and wetland plants is TerrPlant. These models are23

parameterized using relevant reviewed registrant - submitted environmental fate and transport data. PRZM (v3.12.2, May

2005) and EXAMS (v2.98.4.6, April 200 5) are screening simulation models coupled with the input shell PE 5.pl (August, 2007) to generate daily exposures and 1 - in 10 year EECs of fluazinam plus its transformation products, that may occur from spray

drift and runoff to surface water bodies adjace nt to application sites. PRZM simulates pesticide application, movement and transformation on an agricultural field and the resultant pesticide loadings to a receiving water body via runoff, erosion and spray drift. The EXAMS model simulates the fate of the pesticide and resulting concentrations in the water body . The standard scenario used for ecological pesticide assessments assumes application to a 10 - hectare agricultural field that drains into an adjacent 1 - hectare water body that is 2 meters deep ( 20,000 m 3 volume) with no outlet. PRZM/EXAMS is used to estimate screening - level exposure of aquatic organisms to fluazinam plus its transformation products . The measure of exposure for aquatic species is the 1 - in - 10 year return peak or rolling mean conc entration. The 1 - in - 10 year peak is used for estimating acute exposures of direct effects to aquatic organisms. The 1 - in - 10 - ye ar 60 - day

mean is used for assessing chronic exposure to fish and aquatic - phase amphibians. The 1 - in - 10 - ye ar 21 - day

mean is used for assessing aquatic invertebrate chronic exposure. Exposure estimates for terrestrial animals assumed to be in the target area are derived using the T - REX model (version 1.3.1, 12/07/2006). For granular pesticides (not applicable for fluazinam) , this i ncludes the amount of pesticide per square foot, used in LD 50 per square foot risk assessment calculations. EECs for terrestrial plants inhabiting dry and wetland areas are derived using TerrPlant (version 1.2.2, 12/26/2006). This m odel uses estimates of pesticides in runoff and in spray

drift (assumed to be 0% for granulars) to calculate EECs. EECs are based upon solubility, application rate and minimum incorporation depth. 7.3. Measures of Effect Ecological effects data are u sed as measures of direct and indirect effects to biological receptors. Data are ty

picall y obtained from registrant - submitted studies or from literature studies identified by ECOTOX. The ECOTOX database provides more ecological effects data in an attempt to bridge existing data gaps. ECOTOX is a source for locating single chemical toxicity data and potential chemical mixture toxicity data for aquatic life, terrestrial plants, and wildlife. ECOTOX was created and is maintained by the USEPA, Office of Res earch and Development, and the National Health and Environmental Effects Research Laboratory's Mid - Continent Ecology Division. Where available, sub - lethal effects observed in both registrant - submitted and open literature studies will be evaluated qualitatively . Such effects may include behavioral changes ( e.g. , lethargy and changes in coloration). Quantitative assessments of risks, though, are limited to those endpoints that can be directl y linked to the Agency ’s assessment endpoints of impaired survival , growth and reproduction.24

The assessment of risk for direct effects to non - target organisms makes the assumption that the toxicity of fluazinam to birds is similar to terrestrial - phase amphibians and reptiles. The same assumption i s made for fish and aquatic - phase amphibians. The acute measures of effect used for animals in this assessment are the LD 50 , L C 50 and EC 50 . LD stands for "Lethal Dose", and LD 50 is the amount of a material, given all at once, that is estimated to cause the death of 50% of the test organisms. L C stands for “Lethal Concentration” and L C 50 is the concentration of a chemical that is estimated to kill 50% of the test organisms. EC stands for “Effective Concentration” and the EC 50 is the concentration of a c hemical that is estimated to produce a specific effect in 50% of the test organisms. Endpoints for chronic measures of exposure for listed and non - listed animals are the NOAEL/NOAEC and NOEC. NOAEL stands for “No Observed - Adverse - Effect - Level” and refers to the highest tested dose of a substance that has been reported to have no harmful (adverse) effects on test organisms. The NOAEC ( i.e. , “No - Observed - Adverse - Effect - Concentration”) is the highest test concentration at which none of the observed effects were statistically different from the control. The NOEC is the No - Observed - Effects - Concentration. For non - listed plants, only acute exposures are assessed ( i.e. , EC 25 for terrestrial plants and EC 50 for aquatic plants); for listed plants either the NOAEC or EC 05 is used. 7.4. Integration of Exposure and Effects Risk characterization is the integration of exposure and ecological effects characterization to determine the potential ecological risk from the use of pesticides and the likelihood of direct and indirect effects to non - target organisms in aquatic and terrestrial habitats. The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on non - target species. For the assessment of risks, the risk quotient (RQ) method is used to compare exposure and measured toxicity values. EECs are divided b y acute and chronic toxicity values. The resulting RQs are then compared to the Agency ’s Levels of Concern (LOCs) (USEPA 2004). These criteria will be u sed to indicate when fluazinam ’ s uses, as directed on the label, have the potential to cause adverse direct or indirect effects to non - target organisms. In addition, incident data from the EII S will be considered as part of the risk characterization. 7 .5. Deterministic and Probabilistic Assessment Methods The quantitative assessment of risk will primarily depend on the deterministic point - estimate based approach described in the risk assessment. An effort may also be made to further qualitatively

des cribe risk using probabilistic tools that the Agency has developed. These tools have been reviewed b y FIFRA Scientific Advisory Panels (http://www.epa.gov/scipoly/sap/index.htm) and have been deeme d as appropriate means of refining assessments where deterministic approaches have identified risks.25

7.6. Endangered Species Assessments Consistent with the Agency ’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks t o Federally- listed threatened and/or endangered (listed) species from registered uses of fluazinam . This assessment will be conducted in accordance with the Overview Document (USEPA 2004), provisions of the ESA, and the Services’ Endangered Species Consultation Handbook (USFWS/NMFS, 1998). The assessment of effects associated with the registration of fluazinam is based on an action area. The action area is considered to be the area directly or indirectl y affected by the federal action, as indicated b y th e exceedance of Agency L evels of Concern (LOCs) used to evaluate direct or indirect effects. The Agency ’s approach to defining the action area under the provisions of the Overview Document (USEPA 2004) considers the results of the risk assessment process to establish boundaries for that action area with the understanding that exposures below the Agency ’s defined LOCs constitute a no - effect threshold. For the purposes of this assessment, attention will be focused on the footprint of the action (i.e., the area where fluazinam appli cation occurs), plus all areas where offsite transport may result in potential exposure that exceeds the Agency ’s LOCs. Specific measure s of ecological effect that define the action area for listed species include any direct and indirect effects and/ or potential modification of its critical habitat, including reduction in survival, growth, and reproduction as well as the full suite of sub - lethal effects available in the effects literature. Therefore, the action area extends to a point where environmental exposures are below any measured lethal or sub - lethal effect threshold for any biological entity at the whole organism, organ, tissue, and / or cellular level of organization. In situations where it is not possible to determine the threshold for an observed effect, the action area is not spatiall y limited and is assumed to be the entire United States. 7.7. Drinking Water Assessment A drinking water assessment will be conducted to support future human health risk assessments of f luazinam . The drinking water assessment will incorporate model estimates of fluazinam ( fluazinam total residues of concern) in surface and ground waters. Concentrations in surface waters will be estimated using FQPA Index Reservoir Screening Tool (FIRST, v.1.1.1, 12/18/07) (or subsequentl y using PRZM/ EXAMS - see description above , if refinements are required) . Ground water estimates of concentrations will be made using the Screening Concentration in Ground Water (SCI - GROW) model (v.2.3, July 2003). The drinking water assessment will also include a summary

of available surface and ground water monitoring data. 7.8. Preliminary Identification of Data Gaps 7.8.1 . Fate The environmental fate database is substantiall y complete.26

835.6100 : Terrestrial Field Diss ipation . EFED believes that the available Terrestrial Field Dissipation studies provide useful supplemental information about the parent fluazinam. However, poor recoveries for two of the transformation products upon storage stability cast doubts over th e results obtained for them in the field. The registrant submitted two new terrestrial field dissipation studies (MRID#s 45584207 and 45584208). These studies are currentl y in review. 835 .6100 , 835.6200 : Environmental Chemistry Method s (ECM s ) and Indep endent Laboratory Validation s (ILV s ) for Soil, Water and Sediment . ECMs associated with the Terrestrial Field Dissipation study (F ield dissipation §158.1300; OPPTS guidelines 835.6100, 835.6200, and 835.6300) , along with successful confirmatory method tri al s (validation) by an independent laboratory ( i.e. ILV s ) , are required. I f there is risk concern for a given taxon, ECMs should be available for the environmental media in which organisms of the taxon reside. These ECMs should have limits of quantitatio n for the residues of concern that are lower than the relevant toxicological levels of concern. The latter risk assessments conducted on fluazinam indicated risk concerns for organisms living in freshwater and estuarine/ marine bodies of water. In additi on, there were risk concerns for estuarine/ marine organisms living in the benthos. Therefore, ECMs for water and sediment are required in addition to the ECM for soil . The ECMs should include parent and those residues found in the laboratory studies that exceeded 10% of the applied. The following appear to be the residues of concern for each media:  Soil

– parent and HYPA  W ater

– parent, DCPA, HYPA, CAPA, DAPA and AMPA  Sediment

– parent, DAPA and AMPA The registrant is encouraged to submit state - of - the - art environmental chemistry methods; further, multi - residue methods (MRMs) for soil, water and sediment are preferred. Table 7 lists the status of the environmental fate d ata requirements . Table 7 . Summary of Environmental Fate Data Requirement s for Fluaz inam Study Identification Use Pattern 1 Does EPA Have

Data To Satisfy This Requirement? Bibliographic Citation Must Additional Data Be Submitted Under FIFRA 3(c)(2)(B)? §158. 1300 ENVIRONMENTAL FATE Degradation Studies - Lab: 835.212 0 Hydrolysis 1,2 Yes 42208412 No 835.2240 Photodegradation In Water 1,2 Yes 44807312, 43521009 , 45584204 No 835.2410 Photodegradation On Soil 1,2 Yes 42208413 , 44807313, 45584204 No Me tabolismStudies - Lab: 835.4100 Aerobic Soi l 1,2 Yes 42208413 , 42208414 No27

Table 7 . Summary of Environmental Fate Data Requirement s for Fluaz inam Study Identification Use Pattern 1 Does EPA Have

Data To Satisfy This Requirement? Bibliographic Citation Must Additional Data Be Submitted Under FIFRA 3(c)(2)(B)? 835.4200 Anaerobic Soil 1,2 No 42208413, 42208414 No 835.4400 Anaerobic Aquatic 1,2 Yes 43521010 No 835.4300 Aerobic Aquatic 1,2 Yes 44807314 No Mobility Studies: 835.1230 & 835.1240 Leaching - Adsorption/ D esorption 1,2 Yes 44807314 No 835.1410 Volatility (Lab) 1,2 No NA No Dissipation Studies - Field: 835.6100 Soil 1,2 Yes 44807318, 44807320, 44807316, 44807319, 44807317 , 45584207, 455842 08 In reserve

835.6100 Environmental Chemistry Methods (ECM) and Independent Laboratory Validation (ILV)

– Soil, Water and Sediment 1,2 No N/A Yes Ground Water Monitoring Studies: 835.7100 Ground Water Monitoring 1,2 No NA Reserved §158.630 AQUATIC ORGANISMS TE STING 850.1730 Bioaccumulation in Fish 1,2 Yes 43521012 No §158.1100 SPRAY DRIFT 201 - 1 Droplet Size Spectrum 1,2 No NA No 2 202 - 1 Drift Field Evaluation 1,2 No NA No 2 1. Use Patterns:1=Terrestrial/Food; 2=Terrestrial/Feed. 2. Data requirement covered by submission of the Spray Drift Task Force.

7.8.2 Effects Table 8 lists required ecological studies for fluazinam. Based on new data requirements, a passerine acute oral toxicity test is required. Chronic estuarine/marine fish and aquatic invertebrate studies are requested based on potential exposure to estuarine/marine water bodies and potential risk estimated in previous assessments . Studies will provide information to reduce uncertainty for nontarget and endangered species a ssessments. A whole sediment chronic28

toxicity invertebrate study ( 850 - 1790) is requested to reduce the uncertainty of risk for chronic benthic organisms. Some of the submitted plant studies were deemed invalid and should be repeated. The following plant studies are needed: 123 - 1 : Tier II - Terrestrial Plant Growth - Vegetative vigor. 123 - 2 : Tier II - Aquatic Plant Growth - duckweed ( Lemna gibba ), green algae ( Pseudokirchneriella subcapitata ) , a freshwater diatom (

Navicula ) and a marine diatom (Skeleton ema costatum ). Table 8. Ecological Effects Data Requirem ents for Fluazinam

Data Requirement Use Pattern 1 Does EPA Have

Data To Satisfy This Requirement? (Yes, No, or Partially) Bibliographic

Citation Must

Additional Data Be Submitted Under FIFRA 3(c )(2)(B)? §158.490 WILDLIFE AND AQUATIC ORGANISMS 71 - 1(a) Acute Avian Oral, Quail or Duck 1,2 Yes 42248623, 42248622 No 71 - 1(a) Acute Avian Oral, Passerine 1,2 No Yes 71 - 2(a) Acute Avian Diet, Quail 1,2 Yes 42248624 No 71 - 2(b) Acute Avian Diet, Duck 1,2 Yes 422 4 8625 No 71 - 3 Wild Mammal Toxicity 1,2 NA 71 - 4(a) Avian Reproduction Quail 1,2 Yes 448073 - 23 No 71 - 4(b) Avian Reproduction Duck 1,2 Yes 44831907 No 71 - 5(a) Simulated T errestrial Field Study 1,2 NA 71 - 5(b) Actual Terrestrial Field Study 1,2 NA 72 - 1(a) Acute Fish Toxicity Bluegill 1,2 Yes 4297490 5 No 72 - 1(b) Acute Fish Toxicity (TEP) 1,2 NA 72 - 1(c) Acute Fish Toxicity Rainbow Trout 1,2 Yes 42974904, 42208409 No 72 - 1(d) Acute Fish Toxicity Rainbow Trout (TEP) 1,2 NA 72 - 2(a) Acute Aquatic Invertebrate 1,2 Yes 42974906, 42208410 No 72 - 2(b) Acute Aquatic Invertebrate (TEP) 1,2 NA29

Table 8. Ecological Effects Data Requirem ents for Fluazinam

Data Requirement Use Pattern 1 Does EPA Have

Data To Satisfy This Requirement? (Yes, No, or Partially) Bibliographic

Citation Must

Additional Data Be Submitted Under FIFRA 3(c )(2)(B)? 72 - 3(a) Acute Est/Mar Toxicity Fish 1,2 Yes Yes 44807325

45822102 No No 72 - 3(b) Acute Est/Mar Toxicity Mollusk 1,2 Yes 44807324 No 72 - 3(c) Acute Est/Mar Toxicity Shrimp 1,2 Yes 44807326 No 72 - 3(d) Acute Est/Mar Toxicity Fish (TEP) 1,2 NA 72 - 3(e) Acute Est/Mar Toxicity Mollusk (TEP) 1,2 NA 72 - 3(f) Acute Est/Mar Toxicity Shrimp (TEP) 1,2 NA 72 - 4(a) Early Life Stage Fish 1,2 Yes (FW) 44807327 No No (Estuarine/marine) 458221 - 02 Yes 2 72 - 4(b) Life Cycle Aquatic Invertebrate 1,2 Yes (FW) 4 48073 - 28 No No (Estuarine/marine) 458221 - 01 Yes 2 72 - 5 Life Cycle Fish 1,2 Yes 448073 - 29 No 72 - 6 Aquatic Organism Accumulation 1,2 NA 72 - 7(1) Simulated Aquatic Field Study 1,2 NA 72 - 7(b) A ctual Aquatic Field Study 1,2 NA 850 - 17 9 0 Whole Sediment Chronic Toxicity Invertebrates 1,2 No Yes §158.540 PLANT PROTECTION 122 - 1(a) Seed Germ, Seedling Emergence 1,2 Yes 461728 - 01 No 122 - 2 Aquatic Plant Grow th 1,2 No Yes30

Table 8. Ecological Effects Data Requirem ents for Fluazinam

Data Requirement Use Pattern 1 Does EPA Have

Data To Satisfy This Requirement? (Yes, No, or Partially) Bibliographic

Citation Must

Additional Data Be Submitted Under FIFRA 3(c )(2)(B)? 122 - 1 (b) V egetative Vigor 1,2 No 4 61728 - 02 448073 - 3 2 448073 - 33 Yes 2

123 - 2 Aquatic Plant Grow th 1,2 No No No No Yes No 448073 - 34

458221 - 03 458221 - 04 458221 - 05 458221 - 06 458221 - 07 Yes 3 Yes 3 Yes 3 Yes 3 No Yes 3 124 - 1 Terrestrial Field Study 1,2 NA 124 - 2 Aquatic Field Study 1,2 NA §158.490 NONTARGET INSECT TESTING 141 - 1 Honey Bee Acute Contact 1,2 Yes 422084 - 11 No 141 - 2 Honey Bee Residue on Foliage 1,2 NA 141 - 5 Field Test for Pollinators 1,2 NA 1. Use Patterns:1=Terre strial/Food; 2=Terrestrial/Feed 2 . Guideline study is recommended based on review of unacceptable study submission . 3. Guideline study recommended based on review of invalid nonvascular study submission .31

8. References U.S. Environmental Protection Agency . 1998. Guidelines for Ecological Risk Assessment. Risk Assessment Forum, Office of Research and Development, Washington, D.C. EPA/630/R 95/002F. April 1998. U.S. Environmental Protection Agency . 2000. Risk Characterization Handbook . Science Policy Council, U.S. Environmental Protection Agency , Washington, D.C. 20460. EPA 100 - B - 00 - 002. December 2000. U.S. Environmental Protection Agency . 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency . Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D.C. January 23, 2004. U.S. Environmental Protection Ag ency . 2005. Generic Format and Guidance for the Level I Screening Ecological Risk Assessments Conducted in the Environmental Fate and Effects Division. Office of Pesticide Programs, Washington, D.C. January 24, 2005. U.S. Fish and Wildlife Service (US FWS) and National Marine Fi sheries Service (NMFS). 1998. Endangered Species Consultation Handbook: Procedures for Conducting Consultation and Conference Activities Under Section 7 of the Endangered Species Act. Final Draft. March 199 8.32

Appendix A. S RRD data request justification tables The following proposed Data Call - in table s include rationales for requiring the data requested in this problem formulation, explanations of the utility of the data, and explanations for how the data might impact risk assessment, following the format provided b y SRRD. Guideline Number: 835.6100 Study Title: Environmental Chemistry Methods (ECM) and Independent Laboratory Validation (ILV) for Soil, Water and Sediment Rationale for Requiring the Data A ccording to th e data requirements in 40 CFR Part 158 , ECMs are currently required along with successful confirmatory method trials (validation) by an independent laboratory ( i.e. ILVs). In addition to the method for soil, at this time, methods are required for water and sediment. Acceptable ECMs for the residues of concern (parent and its transformation products) should have levels of quantitation that are adequate to address risk concerns or that are at levels below the toxicological endpoints for the relevant aquatic organisms. The results of previous assessments indicate that there is risk for freshwater fish, and estuarine/ marine invertebrates and benthic organisms. Therefore, ECMs for water and sediment are required in addition to the ECM for soil. The ECMs should include parent and those residues found in the laboratory studies that exceeded 10% of the applied. The registrant is encouraged to submit state - of

- the - art environmental chemistry methods; further, multi -residue methods (MRMs) for soil, water and sediment are preferred. Practical Utility of the Data How did the Agency make its registration decision without these data? Instead of monitoring data, models were utilized to calculate the exposure ( i.e. Estimated Environmental Concentrations, EECs) , using available environmental fate data . Four terrestrial field dissipation studies were conducted with methods for parent and several of the transf ormation products for which there is no ECM or ILV . How will the data be used? The data will be used to verify the suitability of the method s. S ubsequently the methods could be used by states or other enforcement agencies, departments or entities, to monitor concentrations of the residues of concern. Validated analytical methods in environmental media ( a.k.a. , ECM s ) are useful for conducting and evaluating submitted environmental fate and toxicity field and monitoring studies and for addressing potential risks to the environment posed by the use and/or accidental release of pesticides. How could the data impact th e Agency’s future decision - making? If monitoring of the chemical is required or performed, the Agency could be able to determine if the chemical is present in the environment at concentrations that are threatening to wildlife (or to humans, in the case of drinking waters), according to the levels of concern (LOCs). If that is the case, measures to prevent these concentrations to occur could be taken. The data could also be used by enforcement entities like the states or gove rnment agencies or departments . Without these data, the potential for the determination of residues of fluazinam in soil, water and sediment is restricted . The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in use restrictions for fluazinam which may otherwise be avoided, or which are unnecessarily severe.33

Guideline Number: 850 - 2100 Study Title: Passerine Acute Avian Oral Rationale for Requiring the Data Although an acu

te avian oral study was received the Agency updated its data requirements in 40 CFR Part 158 (October 26, 2007) to include an acute oral toxicity study for both a passerine species and either a waterfowl or an upland game species. Prior to starting toxici ty testing, a protocol will need to be provided for review.

o Many passerine species utilize agricultural fields, forests, residential areas and surrounding areas, and, therefore, have the potential to be exposed to pesticides used in agricultural, forest, and residential settings  It is likel y that, for most pesticide use patterns, passerines are more likel y to be exposed to pesticides than upland game species and waterfowl o Passerines are smaller and have faster metabolisms than the waterfowl and upland game bird species traditionally used in avian toxicity

tests which could impact their sensitivity

to chemicals Practical Utility of the Data How did the Agency make its registration decision without these data? Since this is a new requirement, EPA was us ing the results from the toxicity tests for the waterfowl and the upland game bird. How will the data be used? Data from passerine toxicity studies will be used to estimate potential risks to birds associated with uses of fluazinam . The data will reduce uncertainties associated with the current risk assessment for passerine species and will improve our understanding of the potential effects of fluazinam . How could the data impact the Agency’s future decision - making? Because birds significantly contribu te to overall environmental quality, a solid understanding of the potential risks to birds, including passerine species, is essential for sound environmental management. Without acceptable data for fluazinam, the Agency cannot determine the levels of fluaz inam that result in effects to passerine species . If the data indicates that registered fluazinam usage may pose a risk of adverse effects to non - target birds above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk . The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in use restrictions for fluazinam which may otherwise be avoided, or which are unnecessarily se vere.34

Guideline Number: 850.1 450 Study Title: Fish Early Life - Stage (saltwater) Study Rationale for Requiring the Data A c hronic s tudy submitted for estuarine/marine fish in response to th e RED was classified as supplemental based on number of rep licates and no observable response at the highest concentration tested . A new study is required based on the absence of acceptable data to satisfy the guideline for an early life stage estuarine/marine fish study. C hronic studies on estuarine/marine org anisms are required to support uses by which significant concentrations of a chemical are expected to enter into estuarine/marine environments. Persistence in water (e.g., half

- life in water >4 days) can also trigger this data requirement.

Practical Utility of the Data How did the Agency make its re - registration decision without these data? The previous assessment provided for a conditional registration while waiting for acceptable data to be reviewed. How will the data be used? The data would all ow the Agency to determine chronic effects, including effects on reproductive success and growth, to estuarine/marine fish from water column exposure to fluazinam . The effects data would be used to determine the likelihood that the chronic risks can poten tially impact aquatic communities, either by direct effects on fish or by indirect effects on other organisms by reducing their food sources. How could the data change the Agency’s decision, or impact the Agency’s future decision making? By conducting a chronic aquatic risk assessment, the Agency would be able to determine the potential risk to nontarget organisms. For endange red species risk assessments performed without these data, the Agency would have to assume that fluazinam "may affect" endanger ed fish directly (and endangered species from other taxa indirectly), and use of fluazinam mi ght need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use restrictions for fluazinam , which are unnecessarily severe.35

Guideline Number: 850.1 350 Study Title: Aquatic Invertebrate Life - cycle (saltwater) Rationale for Requiring th e Data A c hronic s tudy submitted for estuarine/marine aquatic invertebrates in response to th e RED DCI was classified as supplemental . The chronic mysid study may be upgraded from supplemental if additional raw data is provided. C hronic studies on estuarine/marine organisms are required to support uses by which significant concentrations of a chemical are expected to enter into estuarine/marine environments. Persistence in water (e.g., half

- life in water >4 days) can also trigger this data requirement .

Practical Utility of the Data How did the Agency make its re - registration decision without these data? The previous assessment provided for a conditional registration while waiting for acceptable data to be reviewed. How will the data be used? T he data would allow the Agency to determine chronic effects, including effects on reproductive success and growth, to estuarine/marine invertebrates from water column exposure to fluazinam . The effects data would be used to determine the likelihood that the chronic risks can potentially impact aquatic communities, either by direct effects on invertebrates or by indirect effects on other organisms by reducing their food sources. How could the data change the Agency’s decision, or impact the Agency’s futu re decision making? By conducting a chronic aquatic risk assessment, the Agency would be able to determine the potential risk to nontarget organisms. For endange red species risk assessments performed without these data, the Agency would have to assume that fluazinam "may affect" endangered invertebrates directly (and endangered species from other taxa indirectly), and use of fluazinam might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the fl exibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use restrictions for fluazinam , which are unnecessarily severe.36

Guideline Number: 850 - 1790 Study Title: Chironomid Sediment Toxicity Test Rationale for Requiring the Data No Chironomid sediment toxicity test has been submitted to satisfy the Agency ’s updated data requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007). The lack of chronic estuarine/marine invertebrate toxicity data creates an additional layer of uncertainty for the potential effect of fluazinam on benthic organisms . Additional data has been requested to upgrade the supplemental classification for the chronic estuarine/marine invertebrate toxicity test to reduce the uncertainty associated with the use of fluazinam.

o Benthic organisms inhabit sediment environments that may be exposed to run off or spray

drift from fluazinam applications used in agricultural, forest, and residential settings o The previous a ssessment identified a potential adverse effect for estuarine/marine aquatic organisms based on water column toxicity values . Therefore, there is uncertainty associated with that estimate that can be reduced using data from a toxicity test with benthic or ganisms. o Due to the potential for persistent exposure from fluazinam in sediment identified in the previous assessment, benthic organisms are exposed to fluazinam, which involves different routes of exposure for chronic exposure.

Practical Utility of t he Data How did the Agency make its registration decision without these data? The agency estimated pore water EECs from PRZM/EXAMS using the 

### equilibrium partitioning theory. An a cceptable a cute estuarine/marine aquatic invertebrate study w as used to estimate RQs for the effect of fluazinam on benthic aquatic organisms in the previous assessment. A chronic e stuarine/marine invertebrate study was also used to estimate RQs, but there is additional uncertainty due to the supplemental classification of the study. How will the data be used? Data from sediment toxicity studies will be used to estimate potential risks to benthic organisms associated with uses of fluazinam . The data will reduce uncertainties associated with the current risk assessment for benthic species and will improve our understanding of the potential effects of fluazinam. How could the data impact the Agency’s future decision - making? Although there was uncertainty in estimating the effect of fluazinam on benthic organisms in the previous assessment, there was a potential risk associated with adverse effects identified for estuarine/marine acute and chronic organisms. Acceptable data for benthic organisms will reduce the uncertainty from the previous assessment If the data indicates that registered fluazinam usage may pose a risk of adverse effects to non - target benthic organis ms above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. T he lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in use restrictions for fluazinam which may otherwise be avoided, or which are unnecessarily severe.37

Guideline Number : 850.4150 Study Title : Vegetative vig or, Tier I/ Tier II Rationale for Requiring the Data N o acceptable toxicity data are currently available to assess the risk of fluazinam to terrestrial plants. Since fluazinam has residential outdoor uses, vegetative vigor studies are required. The se phytotoxicity data are needed t o evaluate the level of pesticide exposure to non - target terrestrial and aquatic plants and to assess the impact of pesticides on endangered and threatened plants . Practical Utility of the Data How did the Agency make its re - registration decision without these data? Since EPA was unable to evaluate the potential risks to terrestrial plants associated with the proposed uses of fluazinam , risks were presumed for vegetative vigor endpoints for terrestrial plants. How wil l the data be used? Data from terrestrial plant toxicity studies will be used to estimate potential risks to plants associated with uses of fluazinam . The data will reduce uncertainties associated with the current risk assessment for terrestrial plants and will improve our understanding of the potential effects of fluazinam on plants How could the data impact the Agency’s future decision - making? Because plants form the basis of most habitats and significantly contribute to overall environmental quality , a solid understanding of the potential risks to terrestrial plants is essential for sound environmental management. Without acceptable plant growth data for fluazinam, the Agency cannot determine the levels of fluazinam that result in effects to terrest rial plants . If the data indicates that registered fluazinam usage may pose a risk of adverse effects to non - target terrestrial plants plants above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. T he lack of th ese data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in use restrictions for fluazinam which may otherwise be avoided, or which are unnecessarily severe.38

Guideli ne Number: 850.4400* Study Title: Aquatic Plant Growth - Lem na Rationale for Requiring the Data No acceptable studies have been submitted for vascular aquatic plants . Since the last risk assessment was signed, the Agency has finalized its update to the data requirements in 40 CFR Part 158. In these updated data requirements, which were promulgated on October 26, 2007, vascular plant testing is required for pesticides such as fluazinam with outdoor uses . Fluazinam is a fungicide and therefore EPA assume s it will affect aquatic plant species. Practical Utility of the Data How did the Agency make its re - registration decision without these data? Since EPA was unable to evaluate the potential risks to aquatic plants associated with the use of fluazinam , risks were presumed for vascular aquatic plants. How will the data be used? Data from aquatic plant toxicity studies will be used to estimate potential risks to plants associated with uses of fluazinam . The data will reduce uncertainties associated wi th the current risk assessment for aquatic plants and will improve our understanding of the potential effects of fluazinam on vascular aquatic plants How could the data change the Agency’s decision, or impact the Agency’s future decision making? Becaus e plants form the basis of most habitats and significantly contribute to overall environmental quality, a solid understanding of the potential risks to aqu atic plants is essential for sound environmental management. Without plant growth data for fluazinam , the Agency cannot determine the levels of fluazinam that result in effects to vascular aquatic plants . If the data indicates that registered fluazinam usage may pose a risk of adverse effects to non - target aquatic vascular plants above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. If future endangered species risk assessments are performed without these data, the Agency would have to assume that fluazinam "may affect" endangered plants and use of fluazinam mi ght need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use restrictio ns for fluazinam that may be unnecessarily severe. T39

Guideline Number: 850.5 400 Study Title: Aquatic plant toxicity test using Pseudokirchneriella subcapitata , Navicula pelliculosa and Skeletonema costatum, Tier I Rationale for Requiring the Data Although there is one acceptable study for aquatic nonvascular plants, Anabaena flos - aquae , n o toxicity data are currently available to assess the risk of fluazinam to other aquatic nonvascular plants requested under the DCI . Since fluazinam has r esidential outdo or uses, Tier I aquatic nonvascular plant studies are required. These phytotoxicity data are needed t o evaluate the level of pesticide exposure to non - target aquatic plants and to assess the impact of pesticides on endangered and threatene d plants . Practical Utility of the Data How did the Agency make its re - registration decision without these data? Since EPA was unable to evaluate the potential risks to semi - aquatic plants associated with the proposed uses of fluazinam , risks were pre sumed for aquatic plants. In making its decision, the Agency assumed that the required mitigation measures w ould reduce any potential risk of fluazinam to aquatic nonvascular plants. How will the data be used? Data from Tier I nonvascular aquatic plant toxicity studies will be used to estimate potential risks to plants associated with uses of fluazinam . The data will reduce uncertainties associated with the current risk assessment for nonvascular aquatic plants and will improve our understanding of the potential effects of fluazinam . How could the data impact the Agency’s future decision - making? Because plants form the basis of most habitats and significantly contribute to overall environmental quality, a solid understanding of the potential risks to nonvascular aqu atic plants is essential for sound environmental management. Without plant growth data for fluazinam , the Agency cannot determine the levels of fluazinam that result in effects to aquatic plants . If the data indicates that registered fluaz inam usage may pose a risk of adverse effects to non - target aquatic nonvascular plants above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. T he lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in use restrictions for fluazinam which may otherwise be avoided, or which are unnecessarily severe.40

Appendix B. Ecological Toxicity Test Summaries Birds MRID 4 22486 - 22 : Roberts, N.L ., A. Anderson and I .S. Dawe (1991): An acceptable acute oral mallard duck (

Ana platyrhynchos ) toxicity study resulted in an LD50>4190 mg/kg/body weight. This indicates that fluazinam is practicall y nontoxic to birds. MRID 422486 - 23: An acute avian oral toxicity study resulted in an LD50=1782 mg/kg (1321 - 3595 mg/kg) for the Bobwhite quail ( Colinus virginianus ). Nominal concentrations of 500, 100 and 200 mg/kg were used to estimate the endpoint. This indicates fluazinam is slightly toxic to birds. Although onl y three treatment concentrations were used rather than five, this study was classified as core/acceptable. MRID 422486 - 24: An acute avian dietary toxicity study resulted in an LC 50>10,500 mg/kg for the Bobwhite quail ( Colinus virginianus ). Nominal concentrations of 313, 625, 1250, 2500, 5000 and 10,000 mg/kg were used to estimate the endpoint. This indicates fluazinam is practicall y nontoxic to birds. This study was classified as core/acceptable. MRID 422486 - 25 : Robert s, N.L ., A. Anderson and I .S. Dawe (1991): An acceptable acute dietary mallard duck (

Ana platyrhynchos ) toxicity study randoml y assigned ten birds to six treatment and three control groups. An LC50>10,600 mg/kg was estimated from mean measured concentrati ons of 333, 651, 1260, 2590, 5230 and 10600 mg/kg. This indicates that fluazinam is practicall y nontoxic to birds. MRID 448073 - 23: An reproductive avian toxicity study resulted in a NOEC=200 mg/kg for the Bobwhite quail ( Colinus virginianus ). Nominal concentrations of 750, 1500 and 500 mg/kg for phase I and 50, 200, 350, and 500 mg/kg were used to estimate14 day old survivor weight, the most sensitive endpoint. This study was classified as core/acceptable. MRID 448319 - 07 : Beavers, J.B.; D. Haberle in, L.R. Mitchell and M. Jaber (1996).: An reproductive avian toxicity study resulted in a NOEC=200 mg/kg for the Bobwhite quail ( Colinus virginianus ). Nominal concentrations of 750, 1500 and 500 mg/kg for phase I and 50, 200, 350, and 500 mg/kg were used to estimate14 day old survivor weight, the most sensitive endpoint. This study

was classified as core/acceptable. Terrestri al Invertebrates41

MRID 422084 - 11: A 48 hour contact honey bee study

resulted in an LD50>200 μg ai/bee. This indicates fluazinam is practicall y nontoxic to honey bees. There was no negative control used in this study . The study

was conducted with a solvent control and mean treatment concentrations of 20, 50, 100 and 200 μg ai/bee. This study was classified as core/acceptable. Fis h MRID 429749 - 04 : Gelin, M.D. and J. L aveglia (1992): A 96 hour acute rainbow trout ( Oncorhynchus mykiss ) study resulted in an L C50=36 μg/l based on mean measured concentrations. This study was classified as core/acceptable. This toxicity test indicates that fluazinam is very

highl y toxic to trout. MRID 429749 - 05: A 96 hour acute bluegill study was conducted with a negative control, a solvent control and mean treatment concentrations of 21, 34, 44, 66 and 93 μg/l. The anal ys is resulted in an LC50=52.7 μg/l (47.1 - 59.9 μg/l). This study was classified as core/acceptable. MRID 422084 - 09: A 96 hour acute rainbow trout (S almo gairdneri) study was conducted with a negative control, a solvent control and mean treatment concentrations of 0.057, 0.064, 0.091, 0.16, 0.27 and 0.46 mg/L). The analy sis resulted in an L C50 - 0.13 mg/l (0.10 - 0.18 mg/L). This study was classified as core/acceptable. MRID 448073 - 27: An early life cycle fathead minnow ( Pimephales promelas ) study was conducted with a negative control, a solvent control and mean treatment concentrations of 1.6, 2.7, 5.3, 10 and 23 μg/L). The anal ys is resulted in a NOEC=5.3 μg/L). This study was classified as core/acceptable. MRID 448073 - 29: A 278 day fathead minnow (

Pimephales promelas ) was conducte d with a negative control, a solvent control and mean treatment concentrations of 0.69, 1.4, 2.9, 6.4, and 14 μg/L. The anal ys is resulted in a NOEC=0.69 μg/L. This study was classified as core/acceptable. MRID 448073 - 25: Machado, M.W. (199 3).A 96 hour acute marine fish (sheepshead) was conducted with a negative control, a solvent control and mean treatment concentrations of 0.13, 0.22, 0.36, .0.60 and 1.0 mg/l. No mortality was observed in the negative or solvent control. The anal ys is resulted in an LC50=0.12 mg/l (0.08 - 0.24 mg/l). This study was classified as core/acceptable.42

MRID 458221 - 02: Sousa, J.V. (2001). T he chronic toxicity of IKF - 1216 Technical (fluazinam) to the earl y life - stage of Sheepshead Minnow ( Cyprinodon variegatus) was studied under flow through conditions for 35 day s (7 - day hatching period and 28 - day post - hatch period). Fertilized embryos (160/treatment), 21 - to 27 - hours old, were exposed to IKF - 1216 Technical at nominal concentrations of 0 (negative and solvent controls), 2. 2, 4.4, 8.7, 17, and 35 ppb. Mean measured treatment concentrations were <0.18 (<LOQ, controls), 1.6, 2.8, 5.9, 12, and 26 ppb a.i., respectively . No treatment - related effects on embryo or larval survival, or on length and weight were observed. The NOEC for all endpoints was 26 ppb a.i., the highest concentration tested. A LOEC was not established. Aquatic Invertebrates MRID 429749 - 06: A 48 hour acute aquatic invertebrate ( Daphnia magna ) was conducted with a negative control, a solvent control and me an treatment concentration s of 34,54 94, 150 and 260 μg/l. The anal ys is resulted in an EC50=220 μg/l (190 - 300 μg/l). This study was classified as core/acceptable. MRID 422084 - 10: A 48 hour acute aquatic invertebrate ( Daphnia magna ) was conducted witho ut a negative control, but with a solvent control and mean treatment concentration s of 0.06, 0.13, 0.22, 0.38, 0.92 and 1.64 μg/l. The anal ys is resulted in an EC50=180 μg/l (140 - 220 μg/l). This study

was classified as core/acceptable. MRID 448073 - 28: A 21 day chronic freshwater invertebrate ( Daphnia magna ) was conducted. The flow through study used a negative control, a solvent control and mean treatment concentrations of 8.9, 16, 33, 68 and 140 μg/l. The anal ys is resulted in an NOAEC=68 μg/l for the most sensitive endpoints of dry weight and reproduction as total number of young per female. This study

was classified as core/acceptable. MRID 448073 - 26: A 96 hour acute estuarine/marine invertebrate ( Mysidopsis bahia ) was conducted. The flow through s tudy used a negative control, a solvent control and mean treatment concentration s of 8.0, 13, 25, 40 and 70 μg/l. The anal ys is resulted in an L C50=39 μg/l (34 - 45 μg/l). This study was classified as core/acceptable. MRID 448073 - 24: A 96 hour acute marine oy ster ( Crassotrea virginica ) toxicity test was conducted. The flow through study used a negative control, a solvent control and mean treatment concentration s of 0.84, 1.4, 2.6, 4.4 and 9.7 μg/l. The anal ys is resul ted in an EC50=4.7 μg/l (3.6 - 6.0 μg/l). This study was classified as core/acceptable. MRID 458221 - 01: Lima. W. (2002). Ina 28 - day life cycle test, Americamysis bahia neonates were exposed under flow - through conditions to IKF - 1216 Technical (fluazinam) at nominal concentrations of 0 (negative and solvent controls), 0.25, 0.50, 1.0, 2.0, and 4.0 ppb. Mean measured concentrations were <0.054 (<LOQ, controls), 0.25, 0.52, 1.0, 2.0, and 3.9 ppb a.i., respectivel y. Prior to sexual maturity and pairing, there were 60 m ys ids/level. At Day 13, 20 pair/level were isolated for individual matings; the remainder of first - generation my sids were43

group retained. First - generation my sids were observed for mortality and signs of abnormal behavior once dail y throughout the study. Once daily during the reproduction period, second generation m ys ids were counted and discarded. Data endpoints included terminal percent survival of first - generation my sids (Day 28; combined sexes), number of young produced per female per repro ductive day , and dry weight and length of surviving first - generation m ys ids (Day 28; gender - specific). Plants Terrestrial MRID 461728 - 01. Stewart, P. (2003): An acceptable seedling emergence Tier I study (MRID 461728 - 01) using the dicots cabbage, carrot, cucumber, lettuce radish, soybean and tomato and the monocots corn, oat , onion and ryegrass was received . The toxicity test resulted in an EC25>0.78lbs a.i./A based on no observed effects at the highest tested concentration. . Aquatic MRID448073 - 34: A 96 hour freshwater algae (Selenastrum caprico rnutum ) toxicity test anal ys is resulted in an EC50=180 μg/l (160 - 200 μg/l). This study was classified as supplemental due to a 96 hour versus 120 hour recommended duration. In addition, the light intens ity exceeded the recommendation. MRID 458221 - 06: Hoberg, J. (2002). In a 96 - hour acute toxicity study , cultures of Anabaena flos - aquae were exposed to Fluazinam under static conditions at nominal concentrations 0 (negative and solvent controls), 13, 25, 50, 100, and 200 ppb a.i. The initial measured concentrations were <0.88 (negative and solvent controls), 12, 26, 36, 72, and 140 ppb a.i. The initial measured concentrations were used instead of the 96 hour measured or means of the 0 and 96 hour measured concentrations because the test material declined to <70% of nominal for both. The 96 - hour cell density

percent inhibitions based on the control were 19, 27, 10, 23, and 30% in the 12, 26, 36, 72, and 140 ppb a.i. treatment groups, respectivel y. Mean ce ll density was significantl y reduced compared to the control for 140 ppb a.i. The cell density NOEC was 72 ppb a.i. based on the Williams Test. The cell density EC 50 was 9,200 ppb a.i. based on a Nuthatch anal ys is

. This study was classified as acceptable.